(27 days)
No
The summary describes image processing and quantification software, but there is no mention of AI, ML, or related concepts like training or test sets for algorithmic development.
No.
The device is a software product that provides image processing and quantification tools for ultrasound images to aid in clinical diagnosis. It does not directly provide therapy or therapeutic benefit.
Yes
Explanation: The software performs image processing, manipulation, and quantification of ultrasound images obtained from the ACUSON SC2000 Diagnostic Ultrasound System. The output of the software, when used by a qualified clinician, is intended to "add information to the study to be used for a clinical diagnosis," which directly relates to the diagnostic process.
Yes
The device is explicitly described as a "software-only product" and a "dedicated software application" that runs on a user's PACS workstation. Its function is image processing and manipulation, which is a software-based task.
Based on the provided information, the syngo® Ultrasound Apps Suite is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- syngo® Ultrasound Apps Suite's function: The syngo® Ultrasound Apps Suite is a software-only product that processes and manipulates ultrasound images. It does not interact with or analyze biological specimens. Its purpose is to enhance and quantify information from existing ultrasound images for use in clinical diagnosis.
- Intended Use: The intended use explicitly states it's for "acceptance, display and digital processing of ultrasound images" and that the use of the application package "can add information to the study to be used for a clinical diagnosis." This aligns with image processing and analysis, not in vitro testing.
Therefore, while the software is used to aid in clinical diagnosis, it does so by processing medical images, not by performing in vitro tests on biological samples.
N/A
Intended Use / Indications for Use
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- eSie Volume Viewer
- eSie LVA
- eSie PISA
- eSie Valves
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinician / user's PACS workstation
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
syngo® Ultrasound Apps Suite™ (sUSAS) is verified, and validated according to the design control requirements of 21 CFR 820.30 and has been subjected to extensive safety and requirements verification testing before release to ensure the device meets all its specifications including conformance to the following standards:
- IEC 62304:2006/A1:2016 Medical Device Software Software Life Cycle Processes ●
- IEC 62366-1:2015, Application of usability engineering to medical devices. ●
- NEMA PS 3.1 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM set). ●
The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to the sUSAS software only plug-in is included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
A risk analysis, in compliance with ISO 14971:2007, for sUSAS was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirm that all software specifications have been implemented and met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.
syngo® Ultrasound Apps Suite™ (sUSAS) is a class II device and uses the same technology and operating principles as the predicate device; eSie Apps Suite (K143254), therefore clinical studies were not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
May 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043
Re: K201062
Trade/Device Name: syngo Ultrasound Apps Suite™ (sUSAS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2020 Received: April 21, 2020
Dear Ms. Dunbar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
1
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201062
Device Name syngo® Ultrasound Apps. Suite™ (sUSAS)
Indications for Use (Describe)
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- · eSie Volume Viewer
- eSie LVA
- · eSie PISA
- · eSie Valves
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1.1.3 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c)
| Date prepared: | May 04, 2020 |
|---|---|
| Part 1. Sponsor: | Siemens Medical Solutions USA, Inc., |
| Ultrasound Division | |
| 685 East Middlefield Road | |
| Mountain View, California 94043 | |
| Contact Person: | Christine Dunbar |
| Senior Regulatory Affairs | |
| Siemens Medical Solutions USA, Inc., | |
| Ultrasound Division | |
| 685 East Middlefield Road | |
| Mountain View, California 94043 | |
| Email: Christine.dunbar@siemens.com | |
| Tel: (925) 374-2045 | |
| Part 2. Device Name: | syngo® Ultrasound Apps Suite™ (sUSAS) |
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture Archiving and Communications System |
| Classification: | Regulatory Class: II |
| Review Category: Tier II | |
| Classification Panel | Radiology |
| CFR Section | 21 CFR §892.2050 |
| Product Code | 90-LLZ |
| Legal Manufacturer: | Siemens Medical Solutions USA, Inc., |
| Ultrasound Division | |
| 685 East Middlefield Road | |
| Mountain View, California 94043 |
4
Part 3. Legally Marketed Predicate Devices
The syngo® Ultrasound Apps Suite™ (sUSAS) as described in this 510(k) submission is substantially equivalent to the company's legally marketed device, the eSie Apps Suite as represented below:
| Primary Predicate
Device | 510(k) Number / Clearance
Date / ProCode | Substantial Equivalence
claimed to: |
|----------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| eSie Apps Suite (Primary
Predicate) | K143254 / 12/10/2014 /
LLZ | Syngo® Ultrasound Apps
Suite VA17A image display,
manipulation, post-
processing with Clinical
Applications Packages
(CAPS)
• Volume Review
• eSie LVA
• eSie PISA
• eSie Valves
• Including image
support for SC2000
v6.0 image data. |
| Secondary Predicate
Device Name | 510(k) Number / Clearance
Date | Substantial Equivalence
claimed to: sUSAS
support clinical image
review and post
processing using the
same CAPS. |
| ACUSON SC2000
Diagnostic Ultrasound
System (v5.1) – VB21A
Reference Predicate | K200585 / 04/22/2020 / IYO | ACUSON SC2000
Diagnostic Ultrasound
system image display,
manipulation, post-
processing with Clinical
Applications Packages
(CAPS)
• Volume Review
• eSie LVA
• eSie PISA
• eSie Valves |
| Reference Predicate
Devices | 510(k) Number / Clearance
Date | sUSAS supports clinical
image review and post
processing using the
same CAPS. |
| Syngo® Dynamics PAC
System, VA30A | K171053 / June 1, 2017 /
LLZ | Syngo Dynamics PAC
System, VA30A and earlier
PACS versions supports the
sUSAS Plug-in and
launches the clinical
applications packages
(CAPS) contained in the
sUSAS application. |
5
Part 4. Device Description
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
Part 5. Intended Use and Indications for Use Statement
The syngo® Ultrasound Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages:
The software supports the following clinical application pack.
- . eSie Volume Viewer
- . eSie LVA
- . eSie PISA
- . eSie Valves
The indications for use for syngo® Ultrasound Apps Suite™ (sUSAS), VA17A remains unchanged from the primary predicate device eSie Apps Suite currently cleared in K143254 except for the device name.
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Part 6. Technological Characteristics as compared to Predicate Device
The subject device: syngo® Ultrasound Apps Suite ™ (sUSAS) is substantially equivalent to the cleared primary predicate device, eSie Apps Suite (K143254) that employs the same fundamental scientific technology and intended use/indications for use.
The clinical applications packages (CAPS) are the same version as used on the currently cleared SC2000 Diagnostic Ultrasound system v6.0 cleared under K200585 to ensure consistent functionality between the SC2000 Diagnostic Ultrasound system and the sUSAS software plug-in applications. Therefore, the SC2000 v6.0 K200585 is a secondary predicate as v6.0 contains the same CAPS as sUSAS VA17A and syngo® Dynamics PACs K171053 will be used as a reference predicate since the sUSAS application is installed as a plug-in and will be included in the comparison table.
A comparison table as Table 2 is provided on the following page:
7
| Table 1: List of Technological Characteristics and SE Comparison Table | ||||
|---|---|---|---|---|
| Feature / | ||||
| Characteristic | eSie Apps Suite K143254 | |||
| (Predicate device) | ACUSON SC2000 | |||
| Ultrasound System | ||||
| K200585 | ||||
| (Secondary Predicate) | ||||
| Syngo Dynamics K171053 | ||||
| (Reference Predicate) | syngo® Ultrasound Apps | |||
| Suite™ (SUSAS) | ||||
| (this submission) | ||||
| Device Classification | ||||
| (Device class/Product | ||||
| code & | ||||
| panel/description) | Class II | |||
| LLZ & Radiology | ||||
| Picture archiving and | ||||
| Communications system | Class II | |||
| IYN, IYO, ITX, OBJ | ||||
| Ultrasonic pulsed doppler | ||||
| imaging system – and - | ||||
| Class II | ||||
| LLZ - PACS | Class II | |||
| LLZ & Radiology | ||||
| Picture archiving and | ||||
| Communications system | ||||
| Intended | ||||
| Use/Indication for | ||||
| Use statement | eSie Apps Suite software is a | |||
| software-only product to be | ||||
| run on a user's PACS (Picture | ||||
| Archiving and | ||||
| Communication System) | ||||
| workstation. It is intended | ||||
| to launch Siemens CAPs | ||||
| (Clinical Application | ||||
| Packages) for image | ||||
| processing, including the | ||||
| acceptance, transfer, display | ||||
| and digital processing of | ||||
| ultrasound images. Digital | ||||
| processing includes image | ||||
| manipulation and | ||||
| quantification on a | ||||
| workstation. Use of a clinical | ||||
| application package by a | ||||
| qualified clinician can add | ||||
| information to the study to be | ||||
| used for a clinical diagnosis. | ||||
| The software supports the | ||||
| following clinical application | ||||
| packages: | ||||
| • eSie Volume | ||||
| Viewer | ||||
| • eSie LVA | ||||
| • eSie PISA | ||||
| • eSie Valves | See clearance letter for | |||
| K200585 in Attachment | ||||
| B2a. | ||||
| See reference device | ||||
| clearance letter for | ||||
| K171053 in Attachment | ||||
| B3. | syngo® Ultrasound Apps | |||
| Suite software is a software- | ||||
| only product to be run on a | ||||
| user's PACS (Picture | ||||
| Archiving and Communication | ||||
| System) workstation. It is | ||||
| intended to launch Siemens | ||||
| CAPs (Clinical Application | ||||
| Packages) for image | ||||
| processing, including the | ||||
| acceptance, transfer, display | ||||
| and digital processing of | ||||
| ultrasound images. Digital | ||||
| processing includes image | ||||
| manipulation and | ||||
| quantification on a | ||||
| workstation. Use of a clinical | ||||
| application package by a | ||||
| qualified clinician can add | ||||
| information to the study to be | ||||
| used for a clinical diagnosis. | ||||
| The software supports the | ||||
| following clinical application | ||||
| packages: | ||||
| • eSie Volume | ||||
| Viewer | ||||
| • eSie LVA | ||||
| • eSie PISA | ||||
| • eSie Valves | ||||
| SAME AS PREDICATE | ||||
| YES -(eSie volume viewer) | Yes - SC2000 6.0 and lower | SAME - (eSie volume viewer) | ||
| ■ | Viewing and | |||
| manipulation of | ||||
| volume datasets | YES -(eSie volume viewer) | |||
| Yes - syngo Dynamics via | ||||
| sUSAS installed | ||||
| ■ | 2D quantitative | |||
| tool for | ||||
| assessment of | ||||
| global and | ||||
| regional | ||||
| myocardial | ||||
| mechanics | No | Yes SC2000 only | ||
| (eSie VVI) | No | |||
| No - syngo Dynamics via | ||||
| sUSAS installed | ||||
| ■ | 3D Left | |||
| Ventricle volume | ||||
| quantitative | ||||
| analyses (Single |
- Multibeat) | YES (eSie LVA) | Yes - SC2000
(eSie LVA) +5 beats | YES (eSie LVA) + 5 beats
Update to number of
cardiac cycles supported
from 3 to 5 beats, SAME
As SC2000 6.0 |
| | | | No - syngo Dynamics via
sUSAS installed | |
| ■ | Quantification of
proximal
isovelocity
surface area | YES (eSie PISA)
2D data acquired with TTE
probe | Yes - SC2000
(eSie PISA) 2D and 3D
volume date acquired with
TTE, TEE and ICE probes.
Color Doppler & B mode. | YES (eSie PISA)
2D and 3D volume date
acquired with TTE, and TEE
probes.
Color Doppler only. |
| | | | No- syngo Dynamics via
sUSAS installed | |
| ■ | 2D Automated
tool to identify
and measure
contours of left
ventricle and
atrium from
transthoracic
exams (TTE) | No | Yes - SC2000
(eSie Left Heart) | No |
| | | | No- syngo Dynamics via
sUSAS installed | |
| ■ | Visualize and
quantify mitral
and aortic valve
anatomy | YES (eSie Valves) | Yes - SC2000
(eSie Valves) | YES (eSie Valves)
Same as SC2000 6.0 with
defect corrections |
| | | | No - syngo Dynamics via
sUSAS installed | |
| ■ | GUDID
Compliance | Yes VA16A | Yes - SC2000 | YES
VA16A |
| | | | Yes - syngo Dynamics | |
| ■ | Volume Load
Performance | 80 secs | N/A for SC2000 | 40 secs
SAME AS VA16A |
| (Volume load
time in volume
review) | | | | |
| ■ Support SC2000
datasets
compatibility | Yes -
VA16A - v5.0
VA16B - v5.1 | Yes - syngo Dynamics
VA30A and earlier via sUSAS
installed. | Yes, SC2000
6.0 clearance (K200585) | |
| ■ eSie PISA and
TTE (only
support with
TTE Color
Doppler volume
data) | YES VA16A | Yes for SC2000 5.0 and
higher.
Yes, supported on syngo
Dynamics imaging via sUSAS
VA16A | YES (eSie PISA)
Supports TTE Color Doppler
Volume same as VA16A | |
| ■ Syngo Dynamics
(sUSAS support
for SC2000 5.1
data) | YES SyDx VA10 | Yes - syngo Dynamics
With sUSAS VA16B | YES SyDx VA20 | |
| ■ Syngo Dynamics
(sUSAS support
for SC2000 6.0
data) | YES SyDx VA10 | Yes - syngo Dynamics
With sUSAS VA17A | YES SyDx VA20 | |
| ■ Windows 10
Support | No | Yes - SC2000 6.0
Yes - syngo Dynamics via
sUSAS installed | YES (New) for VA17A
SAME as SC2000 6.0 | |
| ■ DICOM Media
Storage Service | YES | Yes - SC2000 6.0 and lower
Yes - syngo Dynamics via
sUSAS installed | YES - SAME | |
| ■ DICOM Structed
Reporting | YES | Yes - SC2000 6.0 and lower
Yes - syngo Dynamics via
sUSAS installed | √ YES - SAME | |
| ■ Display
Improvements | No | SC2000 v6.0 - Yes | Yes aligns with SC2000
6.0 | |
| VR Measurement
Tools
■ (Volume) | No | SC2000 v6.0 - Yes | The ability to measure anatomy
and pathology directly on the
Volume Rendered (VR) images
in CINE and acquired in 4D.
Same as on SC2000 6.0 | |
| Reference Lines
One-click MPR
alignment
■ | No | SC2000 v6.0 - Yes | New Display Feature
Same as on SC2000 6.0 | |
| Volume Reference
Line Projections
eSie Slice / eSie
Lines
■ | No | SC2000 v6.0 - Yes | New Display Feature
Same as on SC2000 6.0 | |
| ■ One-click MPR
A/B Align on
Volume Review
(VR) | No | SC2000 v6.0 - Yes | New Display Feature
Same as on SC2000 6.0 | |
| ■ Trace erase, back
up behavior with
Trackball: B-
Mode | No | SC2000 v6.0 - Yes | Updated Display
Feature Same as on
SC2000 6.0 | |
| ■ D'Art renamed
Single V | No | SC2000 v6.0 - Yes | YES - Consolidated
windows Same as on
SC2000 6.0 | |
8
9
10
Substantial Equivalence Conclusion:
From the information provided in Table 2 above; it is understood that the subject device does not introduce any new fundamental technology or modify the indications of use; therefore, sUSAS VA17A is considered substantially equivalent to the predicate device: the eSie Apps Suite VA15A cleared in K143254 utilizing the same Clinical Applications (CAPS) as cleared on the Secondary predicate ACUSON SC2000 Diagnostic Ultrasound System v6.0 (K20085) The sUSAS VA17A is intended to be a plug-in on a PACS such as the the reference predicate syngo® Dynamics PACS workstation (K171053) or earlier versions.
Part 7. A brief discussion of nonclinical testing submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
svngo® Ultrasound Apps Suite™ (sUSAS) is verified, and validated according to the design control requirements of 21 CFR 820.30 and has been subjected to extensive safety and requirements verification testing before release to ensure the device meets all its specifications including conformance to the following standards:
- IEC 62304:2006/A1:2016 Medical Device Software Software Life Cycle Processes ●
- IEC 62366-1:2015, Application of usability engineering to medical devices. ●
- NEMA PS 3.1 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM set). ●
The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
11
Software Verification and Validation
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to the sUSAS software only plug-in is included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
A risk analysis, in compliance with ISO 14971:2007, for sUSAS was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirm that all software specifications have been implemented and met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.
Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
syngo® Ultrasound Apps Suite™ (sUSAS) is a class II device and uses the same technology and operating principles as the predicate device; eSie Apps Suite (K143254), therefore clinical studies were not required to support substantial equivalence.
Part 9. Safety and Effectiveness Information
Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards. The device does not come into contact with the patient and is only used by trained
professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.
Siemens believes that syngo® Ultrasound Apps Suite, version VA17A is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
Part 10. Conclusion as to Substantial Equivalence Summary
Based on the information provided here in the summary and from the device comparison in Table 2; the syngo® Ultrasound Apps Suite™ (sUSAS); VA17A has the same indications for use as the primary predicate device (K143254) (except new product name); incorporates technological features
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of the primary predicate device and the same Clinical Applications Packages (CAPS) as the primary predicate (K143254) and as the secondary predicate device (K200585) cleared through premarket notification and performance testing which indicates that no new issues of safety or effectiveness are raised.
Siemens Medical Solutions USA, Inc, Ultrasound Business Unit. considers the syngo® Ultrasound Apps Suite™ (sUSAS) VA17A to be substantially equivalent with respect to safety and effectiveness to the previously cleared predicate device for the U.S. market.